Appliance for people with reduced sense of touch or disabled people

ABSTRACT

Disclosed herein are devices, methods and systems for monitoring and detection of pressure on a part of a body of a user. In an embodiment, a device includes a substrate having a contact surface for contacting a user, one or more sacs associated with the contact surface of the substrate, and one or more sensors in communication with the one or more sacs, the one or more sensors adapted to measure changes in pressure in the one or more sacs. The sacs contain a fluidic material configured to transmit pressure. The fluidic material is further configured to be shock-absorbing and pressure-relieving such that the fluidic material is displaceable by an action of the user contacting the contact surface causing the pressure in the fluidic material to be redistributed.

CROSS REFERENCE

This application is a continuation of U.S. patent application Ser. No.15/583,989, filed on May 1, 2017, which is a continuation of U.S. patentapplication Ser. No. 14/433,597, filed on Apr. 3, 2015 (now U.S. Pat.No. 9,636,045, issued May 2, 2017), which claims priority toInternational Patent Application No. PCT/IB2013/002919, filed on Oct. 7,2013, which claims the benefit of priority from Denmark PatentApplication No. PA 2012 70605, filed on Oct. 5, 2012, all of which areherein incorporated by reference in their entireties.

TECHNICAL FIELD

This disclosure relates generally to monitoring and prevention of healthrelated conditions of a subject, and in particular, to a method andapparatus for monitoring and preventing pressure ulcers.

BACKGROUND ART

Pressure ulcers, also called bed sores, are a major health issue.Bedridden patients, wheelchair bound patients, people with limitedmobility or reduced sensation of touch, e.g. those suffering fromdiabetic peripheral neuropathy, have high risk of developing pressureulcers (PUs). PUs can develop quickly and are painful for the patient.They are generally resistant to known medical therapy and, are oftenvery difficult to heal. PUs can cause reduced anatomical or functionalintegrity in patients and can, occasionally lead to life threateningcomplications. Care for patients suffering from PUs is often timeconsuming, personnel intensive and expensive. Once developed, PUsincreased hospital stay, imposing enormous burden on the healthcaresystem and diverting precious personnel resources that may be allocatedfor other patients.

Either static or long-term dynamic or punctual load, which allowspressure marks on an insensitive or passive area on the body, can leadto pressure ulcers if not taken care of in time. Such occurrences ofpressure can occlude blood supply to parts of the body leading to tissueischemia. If such pressure is not relieved over a long period of timetissue ischemia can lead to permanent cell damage causing pressureulcers. The person with normal sensation and mobility would beimmediately alerted while the person without sensation—without knowingit—allows repeated high pressure and/or static load on the same smallplace on the body. This can create sores or precursors thereof.

For example, patients suffering from diabetic peripheral neuropathy havereduced sensation in their extremities and may not sense a wound or skindamage to their hands and/or feet. In such patients, a wound or skindamage on the foot can occur without detection, and the condition canlead to complications such as severe infection, slow healing wounds andrisk of amputation. Therefore it becomes important for staff at thehospital or nursing home to constantly monitor vulnerable areas of thebody and especially observe pressure related alteration of the skin thatmay be precursors of pressure ulcer.

So far, the most effective care for an at-risk patient is to relieve thepressure which, in hospitals, is commonly done by periodicallyrepositioning bed-bound patients. Because every patient has levels ofrisk of occurrence of PUs depending on factors such as age, sex, diseaseconditions, blood pressure, nutrition, etc., some patients may need morefrequent repositioning than others. Determining the schedule forrepositioning is difficult may yet be unable to prevent occurrence ofPUs.

Devices for monitoring patients to prevent and/or detect PUs generallyinclude an array of pressure sensors placed in close proximity to partsof a patient's body that are at a higher risk of forming PUs. Thepressure sensors record pressure on the at-risk parts and provide thedata to a caregiver so that the caregiver may relive the excess pressurefrom particular parts by suitably repositioning the patient. However, ingenerally, such devices are expensive and do not, by themselves, absorbor relieve pressure. For example, it would be rather expensive to changea sock having an array of pressure sensors on a daily basis.Furthermore, there may be problems with machine washing and/orautoclaving, as the connection (e.g., a cable) from the sensor to theelectronics may not be adequately protected. Moreover, such devicestechnologies fail to utilize pressure relieving and shock absorbingareas of the patient's body that could otherwise be used. Furthermore,the dimensions of sensor array devices and spatial constraints forplacing these arrays in proximity to a certain body part limit theavailable locations for placement of such devices. For example, while itmay be suitable to use such devices on a mattress or a sheet, it may notwork in a shoe or a sock because of the limited space available forplacing the sensor without chaffing the user's foot.

SUMMARY

In an embodiment, a device includes a substrate having a contact surfacefor contacting a user, one or more sacs associated with the contactsurface of the substrate, and one or more sensors in communication withthe one or more sacs, the one or more sensors adapted to measure changesin pressure in the one or more sacs. The sacs contain a fluidic materialconfigured to transmit pressure. The fluidic material is furtherconfigured to be shock-absorbing and pressure-relieving such that thefluidic material is displaceable by an action of the user contacting thecontact surface causing the pressure in the fluidic material to beredistributed. The one or more sensors adapted to measure changes inpressure in the one or more sacs.

In an embodiment, a device includes a substrate having a contact surfacefor contacting a user, one or more sacs associated with the contactsurface of the substrate, and one or more sensors in communication withthe one or more sacs, the one or more sensors adapted to measure changesin pressure in the one or more sacs. The sacs contain a fluidic materialconfigured to transmit pressure. The fluidic material is furtherconfigured to be shock-absorbing and pressure-relieving such that thefluidic material is displaceable by an action of the user contacting thecontact surface causing the pressure in the fluidic material to beredistributed. Changes in pressure in the one or more sacs are measuredusing one or more sensors in communication with the one or more sacs.

In an embodiment, a system includes (i) a device having a substratehaving a contact surface for contacting a user and one or more fluidicmaterial filled sacs associated with the contact surface of thesubstrate, (ii) a controller configured to transmit and/or receive radiofrequency signals to and from the one or more sensors corresponding tothe measured changes in pressure, and (iii) a user feedback device incommunication with the controller, a substrate having a contact surfacefor contacting a user, one or more sacs associated with the contactsurface of the substrate, and one or more sensors in communication withthe one or more sacs, the one or more sensors adapted to measure changesin pressure in the one or more sacs. The sacs contain a fluidic materialconfigured to transmit pressure. The fluidic material is furtherconfigured to be shock-absorbing and pressure-relieving such that thefluidic material is displaceable by an action of the user contacting thecontact surface causing the pressure in the fluidic material to beredistributed. The user feedback device configured to provide anindication to a user based on the measured changes in pressure. Changesin pressure in the one or more fluidic material filled sacs are measuredusing one or more sensors in communication with the one or more fluidicmaterial filled sacs.

In an embodiment, a method includes measuring pressure exerted by aportion of a subject's body on one or more sacs associated with asubstrate having a contact surface for contacting with the portion ofthe subject's body to provide pressure information, and transmitting thepressure information to a receiving station. The pressure informationindicates, using one or more of audio, visual, audiovisual or hapticsignal.

BRIEF DESCRIPTION OF DRAWINGS

In the present disclosure, reference is made to the accompanyingdrawings, which form a part hereof. In the drawings, similar symbolstypically identify similar components, unless context dictatesotherwise. Various embodiments described in the detailed description,drawings, and claims are illustrative and not meant to be limiting.Other embodiments may be used, and other changes may be made, withoutdeparting from the spirit or scope of the subject matter presentedherein. It will be understood that the aspects of the presentdisclosure, as generally described herein, and illustrated in theFigures, can be arranged, substituted, combined, separated, and designedin a wide variety of different configurations, all of which arecontemplated herein.

FIG. 1 depicts one embodiment of a pressure monitoring deviceincorporated in a sock, in accordance with the principles and aspects ofthe present disclosure.

FIG. 2 depicts an illustrative schematic of response of a devicesubjected to a local compressive load, in accordance with the principlesand aspects of the present disclosure.

FIG. 3 depicts an embodiment of a pressure monitoring deviceincorporated in a shoe-sole is controlled using a smartphone, inaccordance with the principles and aspects of the present disclosure.

FIG. 4 depicts an embodiment of a pressure monitoring deviceincorporated in sheet, in accordance with the principles and aspects ofthe present disclosure.

FIG. 5 depicts an embodiment of a wireless pressure monitoring system,in accordance with the principles and aspects of the present disclosure.

FIG. 6 depicts an embodiment of a battery-less wireless pressuremonitoring system, in accordance with the principles and aspects of thepresent disclosure.

FIG. 7 depicts an embodiment with a radio frequency transmitter is alsoused a pressure sensor, in accordance with the principles and aspects ofthe present disclosure.

FIG. 8 depicts a photograph of a working prototype of a pressuremonitoring system, in accordance with the principles and aspects of thepresent disclosure.

DETAILED DESCRIPTION

Before the present methods and systems are described, it is to beunderstood that this disclosure is not limited to the particularprocesses, methods and devices described herein, as these may vary. Itis also to be understood that the terminology used herein is for thepurpose of describing the particular versions or embodiments only, andis not intended to limit the scope of the present disclosure which willbe limited only by the appended claims. Unless otherwise defined, alltechnical and scientific terms used herein have the same meanings ascommonly understood by one of ordinary skill in the art.

It must also be noted that as used herein and in the appended claims,the singular forms “a”, “an”, and “the” include plural reference unlessthe context clearly dictates otherwise. Thus, for example, reference toa “sensor” is a reference to one or more sensors and equivalents thereofknown to those skilled in the art, and so forth. Nothing in thisdisclosure is to be construed as an admission that the embodimentsdescribed in this disclosure are not entitled to antedate suchdisclosure by virtue of prior invention. As used in this document, theterm “comprising” means “including, but not limited to.”

Disclosed herein are devices, methods and systems for monitoring anddetection of pressure on a part of a body of a user. In an embodiment, adevice includes a substrate having a contact surface for contacting auser, one or more sacs associated with the contact surface of thesubstrate, and one or more sensors in communication with the one or moresacs, the one or more sensors adapted to measure changes in pressure inthe one or more sacs. The sacs contain a fluidic material configured totransmit pressure. The fluidic material is further configured to beshock-absorbing and pressure-relieving such that the fluidic material isdisplaceable by an action of the user contacting the contact surfacecausing the pressure in the fluidic material to be redistributed.

As used herein, the term “sensor” refers to a device that measures aphysical quantity and converts it into a signal which can be read by anobserver or an instrument. In an embodiment, a pressure sensor may be adevice for measuring a pressure and converting it into an electricalsignal that can be can be read using an electronic instrument. In suchembodiment, a change in pressure results in an electrical signal or achange in an electrical signal that is correlated with the change inpressure, thereby providing a measure of the change in pressure. Thepressure measured by a pressure sensor may be absolute pressure orrelative pressure, e.g., pressure relative to atmospheric pressure.

Likewise, a temperature sensor may convert a temperature or a change intemperature into an electrical signal and a humidity sensor may converthumidity or a change in humidity into an electrical signal. The humiditymeasured by a humidity sensor may be absolute humidity or relativehumidity. In various embodiments, a sensor may need to be calibrated toprovide a meaningful measure. In some embodiments, a sensor may notconvert a measurement into an electrical signal.

Examples of pressure sensors include, but are not limited to, (i) straingauges wherein stretching of a lead wire leads to a measurable change inresistance of the lead wire; (ii) piezoresistive sensors whereinresistance of the sensor material is sensitive to deformations anddisplacements; (iii) capacitive sensors wherein capacity of the sensoris measurably changed because a deformation causes a change in thedistance between the plates and/or the overlapping area of the plates;and the like.

As used herein, the term “fluidic material” refers to a gas, a liquid, agel, or a pressure absorbing solid, e.g., foam. Examples of fluidicmaterial include, but are not limited to, ethylene vinyl acetate,rubber, silicone rubber, Polyurethane rubber (PUR), neoprene, or air.Terms “fluidic material sac,” or “fluidic material filled sac,” or “sacfilled with fluidic material” are used interchangeably and refer to acavity disposed in a substrate, the cavity being filled with a fluidicmaterial such as a gas, a liquid, a gel, or a pressure absorbing solid.The fluidic material filled sac can be made from a textile fabricmaterial such as, for example, nylon, spandex, silk, wool, cotton,polyester, and the like, or a combination thereof. In other embodiments,the fluidic material filled sac can be made from a pliable material suchas, for example, rubber, plastic, silicone, neoprene and the like, orany combination thereof.

In some embodiments, the fluidic material in the fluidic material filledsac is chosen such that excess pressure at a localized area of the sacis redistributed throughout the sac by displacement of the fluidicmaterial, thereby relieving the pressure from the localized area.Furthermore, such a sac filled with a fluidic material enablesabsorption and dissipation of sudden changes in pressure, thereby actingas a shock-absorber. As such, a sac filled with a fluidic materialdescribed herein can act as a pressure-relieving and shock-absorbingdevice for a user.

In many embodiments, a plurality of fluidic material filled sacs influidic material conducting communication with each other to form anetwork may be used. The fluidic material fluidic material in such anetwork of fluidic material filled sacs may redistribute pressure from asmall localized area over a larger area, thereby relieving excesslocalized pressure. Furthermore, such a network also enables absorptionand dissipation of sudden changes in pressure, thereby acting asshock-absorber. As such, a network of sacs filled with a fluidicmaterial described herein can act as a pressure-relieving andshock-absorbing device for a user.

As used herein, the term “user” refers to a subject, human or animal,that uses the device or system disclosed herein. A user may be a personat risk for pressure ulcers such as, for example, a bed-ridden subject,a patient of diabetic peripheral neuropathy, a wheel-chair bound person,and the like. In some embodiments, a user may be a subject sufferingfrom pressure ulcers.

FIG. 1 depicts one embodiment of a pressure monitoring deviceincorporated in a sock, in accordance with the principles and aspects ofthe present disclosure. Size of the sock 1 is adapted to the individualuser, so it fits comfortably. A pillow-like region forms the substrate 2and surrounds the underside and the front part of the foot of a user.Fluidic material filled sacs 3 are disposed in the pillow-like substrateand are configured to transmit the changes to various internal andexternal factors (e.g., pressure, temperature, humidity and the like) toone or more sensors 4 disposed on the substrate.

In some embodiments, substrate 2 is made of thin, flexible, resilientand elastic textile product. Examples of materials that may be used formaking substrate 2 include, but are not limited to, nylon, spandex,silk, wool, cotton, polyester, and the like, or a combination thereof.Contact surface 6 is the surface of substrate 2 that engages or comes incontact with the user's foot. Suitable permeability for water vapour andbacteriostatic properties are desirable for the material of the contactsurface so as to reduce risk of unwanted infections and for usercomfort. Material of contact surface 6 can be natural or syntheticfibres.

Associated with contact surface 6 of substrate 2 is disposed one or morefluidic material filled sacs 3 configured such that the fluidic materialis displaceable between different sacs by an action, e.g. movement ofthe foot, of the user contacting the contact surface. Such configurationallows for fluidic material pressure in the one or more sacs 3 to beredistributed so as to dissipate and relieve excess pressure from alocalized portion of a user's body in contact with contact surface 6.

In various embodiments, fluidic material filled sacs 3 can be secured onportions of substrate 2 by means of thermoweld, bonding, molding,laminating, sewing or any other suitable mechanism. In an embodiment,fluidic material filled sacs 3 have a meandering pattern. In someembodiments, fluidic material filled sacs 3 may be made of silicone, orsimilar compressible material that is capable of redistributingpressure. In an embodiment, a surface of the fluidic material filledsacs coincides with the contact surface.

One or more sensors 4 may be disposed in communication with one or morefluidic material filled sacs 3. The sensors 4 may include, for example,pressure sensors, temperature sensors, humidity sensors, blood pressuresensors, and the like. In one embodiment, one or more pressure sensorsare disposed and secured inside one of fluidic material filled sacs 3.In another embodiment, one or more pressure sensors are disposed andsecured on an outer surface of one of fluidic material filled sacs 3. Inyet another embodiment, one or more pressure sensors are associated withcontact surface 6 of substrate 2.

In some embodiments, one or more sensors 4 are connected to atransmitter (not shown) that can transmit the data measured by one ormore sensors 4 from the measurement area to a remote receiver 5. Invarious embodiments, the transmitter may use communication technologiessuch as, for example, Radio Frequency communication (RF), Near FieldCommunication (NFC), Bluetooth, Bluetooth low energy (BLE), and thelike.

In an embodiment, the transmitter is an RF transmitter. RF transmittersare widely used for uniquely identifying objects using radio frequencyelectromagnetic signals. Examples of uses of RF transmitter include, butare not limited to, inventory control, theft protection, monitoringtires pressure in cars, and the like. Typical RF transmitters use an RFIdentifier (RFID) which consists of transmitter (tag) for transmitting aunique identifier and other data to RF Readers, which are configured toreceive and decode data transmitted by the RFID. The tag is typicallycomposed of an antenna and a circuit to control a microchip. In someembodiments, the tag's microchip and antenna may both be used for themeasurement of pressure. An RF tag may be a passive tag or an activetag. A passive tag has no internal source of energy and therefore, maynot require any maintenance. A passive RFID tag is activated only whensending a specific radio signal. At such time the tag “wakes up” andtransmits a unique ID number and a characteristic measurable resistancewhich depends on the pressure of the material it is attached to.

In various embodiments, the RF transmitter may be disposed at a locationwhere it is not obstructive to the user and does not create pressurepoints. For example, the RF transmitter may be glued to a sole or sewninto a sock. In some embodiments, remote receiver 5 may be, for example,a bracelet, a mobile phone, remote control or the like. Remote receiver5, in some embodiments, may be configured to provide a feedback to theuser and/or a caregiver attending to the user. The feedback system canbe embodied with, e.g., colored light, to indicate when a foot issubjected to undesirable stresses.

In various embodiments, a RF transmitter itself may act as a pressuresensor a described elsewhere herein (in reference to FIG. 7). In suchembodiments, the RF transmitter may be placed directly at the measuringarea, e.g. at one of fluidic material filled sacs 3 as a direct pressuresensor, or in proximity as an indirect pressure sensor where thepressure signal from one area is being transmitted to the sensor via oneor more other areas.

In one embodiment fluidic material filled sacs 3 form a tree-likestructure whereby different sacs are in fluidic material conductingcommunication with each other via the branches so that pressure changescan be transferred from a fluidic material filled sac in one area to oneor more fluidic material filled sacs in another area via the branches.In some embodiments, fluidic material filled sacs 3 may be filled usinga movable liquid or gel which, in addition to transferring the pressurechanges, can also massage and support the blood circulation duringoperation. Such configuration provides the advantage that any excesspressure affecting the contact surface is distributed over a largerarea, thereby minimizing its deleterious effects. The material influidic material filled sacs 3 can move, and can be used to measure thepressure or change in pressure using one of or more sensors 4. Inembodiments with a transmitter, and a remote receiver, measurements ofpressure or change in pressure are further transmitted to the remotereceiver via the transmitter.

FIG. 2 depicts an illustrative schematic of response of a devicesubjected to a local compressive load, in accordance with the principlesand aspects of the present disclosure. 201 depicts a schematic drawingof fluidic material filled sac 3 is shown. 202 schematically depicts theeffect of subjecting fluidic material filled sac 3 to a localcompressive load. 203 schematically depicts how the local compressiveload is quickly eliminated by the pressure being dispersed to the entirematerial. 204 schematically depicts that the material used to fillfluidic material filled sac 3 is resilient and can expand if necessary.205 schematically depicts how the pressure changes (both static anddynamic changes) in the material in fluidic material filled sacspropagate to one or more sensors 4.

FIG. 3 depicts an embodiment of a pressure monitoring deviceincorporated in a shoe-sole is controlled using a smartphone, inaccordance with the principles and aspects of the present disclosure.The shoe sole 302 acts as the substrate. Sensors 304 are placed on theunderside of the shoe sole. 305 schematically depicts an example of userinterface for a remote receiver in the form of a smart-phone.

In various other embodiments, substrate may be an article in contactwith a user's body. Examples of substrates include, but are not limitedto, sheets, mattresses, in-soles of shoes, socks, gloves, seat cushions,seat covers, and the like. A skilled artisan will be able to contemplateother embodiments of pressure monitoring devices in accordance withvarious principles and aspects of the present disclosure.

For example, FIG. 4 depicts an embodiment of a pressure monitoringdevice wherein the substrate is a sheet (or a mattress cover). 403schematically depicts an example of placement of fluidic material filledsacs. 404 schematically depicts an example of placement of sensors.Other components of the pressure monitoring device may be suitablyplaced by one skilled in the art in accordance with various aspects andprinciples disclosed herein.

One advantage of such a device is that the sensors and associatedelectronics may be located visibly, hidden away from the measurementarea, or can be removable. This means that the sensors and associatedelectronics can be removed, to facilitate cleaning, including themachine-washing of the device.

In one embodiment, a pressure monitoring system may include a devicecomprising: (i) a substrate having a contact surface for contacting auser; (ii) one or more fluidic material filled sacs associated with thecontact surface of the substrate, and (iii) one or more sensors incommunication with the one or more fluidic material filled sacs. Thesacs contain a fluidic material configured to transmit pressure. Thefluidic material is further configured to be shock-absorbing andpressure-relieving such that the fluidic material is displaceable by anaction of the user contacting the contact surface causing the pressurein the fluidic material to be redistributed. The one or more sensors areadapted to measure changes in pressure in the one or more fluidicmaterial filled sacs. The one or more sensors are in communication withat least one transmitter adapted to transmit a measurement by the one ormore sensors. The system further includes a controller configured totransmit and/or receive signals to and from the one or more sensorscorresponding to the measured changes in pressure, and a user feedbackdevice in communication with the controller. The user feedback device isconfigured to provide an indication to a user based on the measuredchanges in pressure.

In some embodiments, the at least one transmitter is adapted to transmitwireless signals using technologies such as, for example, RadioFrequency communication (RF), Near Field Communication (NFC), Bluetooth,Bluetooth low energy (BLE), and the like. The controller is adapted totransmit and/or receive signals compatible to the transmitter.

Receiver containing electronics and user feedback device as display,speakers, and/or an LED light need not be placed on the substrate. Thesecan be placed anywhere on the user interface device or used in theimmediate vicinity of the substrate, thereby avoiding placement of hardmaterials at sites that have high risk of forming pressure ulcers.Additionally, the signal and the power cable may be completely avoidedby the sensors and electronics to wirelessly transmit data from therecorded measurement range to the remote receiver, which can be placedat a place on the device or in the vicinity of the latter.

In various embodiments, the user feedback device may be configured toprovide an indication or an alert to a user and/or a caregiver attendingto the user if the pressure information indicates a pressure in excessof a pre-determined threshold and/or for a duration longer than apre-determined period of time. The threshold pressure and period of timemay be determined by the user and/or the caregiver based on factors suchas, for example, age, sex, weight, blood pressure, and/or other factorsrelating to the user that determine the user's risk of contractingpressure ulcers.

FIG. 5 depicts the flow of signals in a wireless pressure monitoringsystem, in accordance with the principles and aspects of the presentdisclosure. The embodiment depicted in FIG. 5 includes a temperaturesensor to account for pressure changes due to temperature changes. At501 temperature and pressure data is measured using one or more sensors.This data is encoded and preprocessed at 502 and delivered to the RFtransmitter at 503. At 504, the antenna of the RF transmitter transmitspre-processed pressure and temperature data as an RF signal which isreceived, at 505, by the antenna of the RF receiver. The RF receiver, at506, delivers the signal to the controller. At 507, the controllerdecodes the pressure and temperature data, performs additional signalprocessing (if required) and delivers it to the user feedback device. At508, the user feedback indicates the temperature and pressure data tothe user.

In various embodiments, the controller and the user feedback device maybe incorporated in a single device such as, for example, a smartphone, alaptop computer, a tablet computer, a dedicated handheld device, and thelike. The user feedback device may indicate a feedback using, forexample, audio, audiovisual, visual, or haptic signals.

Various portions of electronics used in the system of the embodimentdescribed with respect to FIG. 5 may be powered using an internalbattery. For example, a battery may be disposed in one of the fluidicmaterial filled sacs and be connected to the one or more sensors and theRF transmitter. The energy required for preforming the pressure and/ortemperature measurements (as well as other measurements whereapplicable) as well as for encoding and pre-processing the measurementdata may be provided by such a battery. Furthermore, such a battery mayalso provide energy required by the RF transmitter for transmitting thepressure and temperature data (as well as other data where applicable).Such embodiments may provide continuous real-time data from themeasurements. However, such embodiments may be limited in time of use byfailure of the internal battery which may need to be replacedperiodically and may increase the operating costs. In some otherembodiments, a connection lead (not shown) may be provided to the sensorand/or the RF transmitter from outside the substrate. This connectionlead may be used to provide energy (using a battery or any other sourceof electricity). In yet other embodiments, the system may be modified towork without an internal battery.

In one embodiment, as depicted in FIG. 6, the system lacks an internalbattery used to power the sensors and the RF transmitter. In such anembodiment, the one or more sensors are connected to an RF transceiverwhich is enabled to harvest energy from a received RF signal. Thisenergy is used to power the sensor(s) to allow the sensor(s) to performthe desired measurements. Alternatively, such an embodiment may use apassive RF tag.

FIG. 6 depicts an embodiment of a battery-less wireless pressuremonitoring system, in accordance with the principles and aspects of thepresent disclosure. At 608, a user or a caregiver requests, through theuser feedback device, for pressure and/or temperature data. The requestis transmitted through the controller, to the RF transmitter (through607, 606, 605, and 604, indicated by arrows pointing left). At 603, theRF transceiver harvests energy from the signal it receives and powersthe encoder and the sensor(s) (as indicated by the arrows pointing leftand labeled power). At 601 temperature and pressure data is measuredusing one or more sensors. This data is encoded and preprocessed at 602and delivered to the RF transmitter at 603. At 604, the antenna of theRF transmitter transmits pre-processed pressure and temperature data asan RF signal which is received, at 605, by the antenna of the RFreceiver. The RF receiver, at 606, delivers the signal to thecontroller. At 607, the controller decodes the pressure and temperaturedata, performs additional signal processing (if required) and deliversit to the user feedback device. At 608, the user feedback indicates thetemperature and pressure data to the user.

FIG. 7 depicts an embodiment with a radio frequency transmitter is alsoused a pressure sensor, in accordance with the principles and aspects ofthe present disclosure. In an embodiment, a pressure sensor consists ofone or more of the passive or active RF tags that can be embedded in afluidic material filled sac for radio communication and for measuringboth static and dynamic pressure changes. When load on the fluidicmaterial filled sac increases, the antenna embedded in the fluidicmaterial filled sac gets stretched resulting in a change in theantenna's detectable complex resistance. This can be used to measure thechange in pressure experienced by the fluidic material filled sac.

The devices and systems described herein open new possibilities for aperson to monitor problem areas on the body continuously in his dailylife, which in turn opens up new opportunities for long-term monitoringof chronic wounds.

FIG. 8 depicts a photograph of a working prototype of a pressuremonitoring system, in accordance with the principles and aspects of thepresent disclosure. The photograph shows a sheet. Each of the 4 areas(811, 812, 813 and 814) of interest on the sheet can by monitoredindependently with a sensor. The pressure and temperature readings canbe wirelessly transmitted to a receiver for decoding and furtherprocessing. It is a short range wireless application where thetransmitter and receiver are separated by a distance of 1 to 50 meter.

In an embodiment, a method of monitoring pressure on a portion of auser's body may include measuring pressure exerted by a portion of asubject's body on one or more fluidic material filled sacs associatedwith a substrate having a contact surface for contacting with theportion of the subject's body to provide a pressure information, andtransmitting the pressure information to a receiving station. Thepressure information is used to indicate a pressure in excess of apredetermined threshold using one or more of audio, visual, audiovisualor haptic signal.

The predetermined threshold may be set by the user and/or the caregiverdepending on the age, sex, weight, blood pressure, and/or other factorsof the user that determine the user's risk of contracting pressureulcers. Alternatively, a caregiver may provide such recommendation basedon such or other factors deemed relevant by the caregiver.

In various embodiments, the method may be executed using the devices orsystems described herein. For example, measuring pressure exerted by auser's foot may be performed using the sock described herein.Furthermore, the sock may also be used to transmit the pressureinformation to the controller or a receiving station of a systemdescribed herein. Likewise, in other embodiments, a user feedback deviceof a system described herein with reference to FIG. 8 may provide theuser and/or caregiver with an indication about the excess pressure onportions of a quadriplegic patent's back.

The foregoing detailed description has set forth various embodiments ofthe devices and/or processes by the use of diagrams, flowcharts, and/orexamples. Insofar as such diagrams, flowcharts, and/or examples containone or more functions and/or operations, it will be understood by thosewithin the art that each function and/or operation within such diagrams,flowcharts, or examples can be implemented, individually and/orcollectively, by a wide range of hardware, software, firmware, orvirtually any combination thereof.

Those skilled in the art will recognize that it is common within the artto describe devices and/or processes in the fashion set forth herein,and thereafter use engineering practices to integrate such describeddevices and/or processes into data processing systems. That is, at leasta portion of the devices and/or processes described herein can beintegrated into a data processing system via a reasonable amount ofexperimentation.

The herein described subject matter sometimes illustrates differentcomponents contained within, or connected with, different othercomponents. It is to be understood that such depicted architectures aremerely exemplary, and that in fact many other architectures can beimplemented which achieve the same functionality. In a conceptual sense,any arrangement of components to achieve the same functionality iseffectively “associated” such that the desired functionality isachieved. Hence, any two components herein combined to achieve aparticular functionality can be seen as “associated with” each othersuch that the desired functionality is achieved, irrespective ofarchitectures or intermediate components.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations may be expressly set forth herein for sakeof clarity.

All references, including but not limited to patents, patentapplications, and non-patent literature are hereby incorporated byreference herein in their entirety.

While various aspects and embodiments have been disclosed herein, otheraspects and embodiments will be apparent to those skilled in the art.The various aspects and embodiments disclosed herein are for purposes ofillustration and are not intended to be limiting, with the true scopeand spirit being indicated by the following claims.

EXAMPLES

Embodiments illustrating the devices, methods and systems describedherein may be further understood by reference to the followingnon-limiting examples:

Example 1: A Sock for Wirelessly Monitoring Pressure on a Foot

FIG. 1 shows a sock for wirelessly monitoring pressure on the foot of apatient. The sock can be made from a suitable textile fabric materialsuch as nylon, spandex, silk, wool, cotton, polyester, and the like, ora combination thereof. A cushioning case or a pouch is stitched to theunderside of the sock. The case or pouch is shaped to match the shapethe underside of the sock such that a user's foot is completelycushioned by the pouch when the user wears the sock. The pouch is madefrom substantially the same textile fabric material as the sock. Fluidicmaterial filled sacs made of silicone and filled with air are placedinside the pouch. The fluidic material filled sacs are provided in ameandering pattern (refer to FIG. 1) such that substantially the entireunderside of the user's foot resides on at least a portion of themeandering pattern at all times while the user is wearing the sock.

An RF antenna acting as a pressure sensor is placed on the underside ofone of fluidic material filled sacs such that the pressure sensorresides directly under heel of the user. A removable battery is providedfor powering the RF antenna. The battery may be placed away from theunderside of the foot, for example, in the sock near the ankle of theuser. A wired connection may be provided from the battery to the RFantenna. A software application (App) on a smartphone communicates withthe RF antenna to provide the user with a measurement of pressure on thefoot on which the sock is worn. The App is configured to alert the userif the pressure is higher is normal for an extended period of time.

Example 2: Monitoring Pressure on a Foot of a Patient

A patient suffering from diabetic peripheral neuropathy in her feet isprovided with a sock of Example 1. When the patient wears the sock, thefluidic material filled sacs act to cushion the foot of the patient onwhich the sock is worn. When the patient is in a position which exertsexcess pressure on a portion of the foot, the fluidic material filledsacs under that portion of the foot redistribute the pressure throughoutthe surface of the foot. Additionally, the RF antenna and the pressuresensor measure the change in pressure and transmit to the smartphoneapplication provided to the patient. The smartphone application altersthe patient about the excess pressure, prompting her to change theposition of her foot.

Example 3: A Sheet for Wirelessly Monitoring Pressure on the Backside ofa Bed-Bound Patient

FIG. 8 shows a working prototype of a sheet for wirelessly monitoringpressure on the back of a bed-bound patient, e.g., a comatose patient ora quadriplegic patient. The sheet consists of 4 distinct compartments(811-814). Each of the compartments can be made from a suitable textilefabric material such as cotton, polyester, and the like, or acombination thereof. The sheet has a length and width sufficient toextend along substantially the entire back portion of a bed-boundpatient, i.e., from head to feet, such that a patient lying with theirback down would cover at least a portion of the sheet. The compartmentsmay be sized such that the patient's head and neck rest on compartment811, the patient's upper back rests on compartment 812, the patient'slower back and hind-quarters rest on compartment 813, and the patient'slegs rest on compartment 814. Inside each compartment is placed a pouchcontaining fluidic material filled sacs filled with silicone. Thefluidic material filled sacs are provided in a meandering shape. Thepouch extends substantially the entire length and width of each of thecompartments.

An RF antenna acting as a pressure sensor is placed substantially at thecenter of each of the pouches inside and under the fluidic materialfilled sacs. A removable battery or other similar power source isprovided for powering the RF antenna. The battery may be placed awayfrom the portion of the compartment that is contact with the body of thepatient. A wired connection may be provided from the battery to the RFantenna. A software application on a bedside monitoring devicecommunicates with the RF antenna to provide the patient and/or acaregiver with a measurement of pressure on backside of the patient. Thesoftware application is configured to alert the patient and/or thecaregiver if the pressure is higher is normal for an extended period oftime.

Example 4: Monitoring the Pressure on the Backside of a Bed-BoundPatient

A comatose patient is provided with a sheet of Example 3. The patientlays backside-down on the sheet such that the fluidic material filledsacs act to cushion the backside of the patient. When the patient is ina position which exerts excess pressure on any portion of the patient'sbody resting on one of the compartments, e.g., a portion upper back nearthe scapula, the fluidic material filled sacs under that portion of thebody redistribute the pressure throughout compartment on which thatportion rests. Additionally, the RF antenna and the pressure sensormeasure the change in pressure and transmit to the smartphoneapplication provided to the patient. If the pressure has not beenrelieved over a pre-determined length of time, the smartphoneapplication alters the caregiver about the static excess pressure,prompting her to change the patients' position.

What is claimed is:
 1. A device comprising: a substrate having a contactsurface for contacting a user; one or more sacs associated with thecontact surface of the substrate, the one or more sacs containing amaterial configured to transmit a pressure to the user, and the materialis configured to be shock-absorbing and pressure-relieving such that thematerial is displaceable by an action of the user contacting the contactsurface causing the pressure in the material to be redistributed; andone or more first sensors in communication with the one or more sacs,wherein the one or more first sensors are connected to one or moretransmitters.
 2. The device of claim 1, wherein the one or moretransmitters comprise a RFID tag, a radio frequency communicationdevice, a near field communication device, a Bluetooth device and/orBluetooth low energy device.
 3. The device of claim 1, wherein the oneor more transmitters comprise a microchip, an antenna and one or moresecond sensors, and wherein the one or more second sensors are anintegral part of the one or more transmitters.
 4. The device of claim 1,wherein the one or more first sensors are located within the one or moresacs.
 5. The device of claim 4, wherein the one or more sacs and the oneor more first sensors are configured to measure a pressure exerted onthe contacting surface by different body parts of the user.
 6. Thedevice of claim 5, wherein the device is configured to determine apressure profile based on the pressure exerted on the contacting surfaceas a function of location and time of contact of the different bodyparts of the user with respect to the contacting surface.
 7. The deviceof claim 6, wherein the pressure profile provides information on anorientation of the body of the user.
 8. The device of claim 7, whereinthe information on the orientation of the body of the user includes datathat the user is lying on (a) the left side of the user, (b) the rightside of the user, or (c) the back of the user.
 9. The device of claim 8,wherein the information on the orientation of the body of the userfurther includes data on an anatomy of the user.
 10. The device of claim9, wherein the data on the anatomy of the user include dimensions of thewidth of the hip of the user.
 11. The device of claim 9, wherein deviceis configured to provide the information on the orientation of the bodyof the user to the user and/or a caregiver.
 12. The device of claim 11,wherein the device is further configured to provide recommendations forrepositioning the user to avoid pressure ulcers in the user.
 13. Thedevice of claim 12, wherein the one or more first sensors comprise oneor more pressure sensors.
 14. The device of claim 13, wherein the one ormore pressure sensors record a pressure on the different body parts ofthe user and provide one or more pressure sensors data to the caregiverso that the caregiver may relive an excess pressure from certain bodyparts of the user by suitably repositioning the user.
 15. A methodcomprising: (1) contacting a user to a device; the device comprising:(a) a substrate having a contact surface, (b) one or more sacsassociated with the contact surface of the substrate, the one or moresacs containing a material configured to transmit a pressure to theuser, and the material is configured to be shock-absorbing andpressure-relieving such that the material is displaceable by an actionof the user contacting the contact surface, and (c) one or more firstsensors in communication with the one or more sacs, wherein the one ormore first sensors are connected to one or more transmitters; and (2)causing the pressure in the material to be redistributed.
 16. The methodof claim 15, wherein the one or more transmitters comprise a RFID tag, aradio frequency communication device, a near field communication device,a Bluetooth device and/or Bluetooth low energy device.
 17. The method ofclaim 15, wherein the one or more transmitters comprise a microchip, anantenna and one or more second sensors, and wherein the one or moresecond sensors are an integral part of the one or more transmitters. 18.The method of claim 15, wherein the one or more first sensors arelocated within the one or more sacs.
 19. The method of claim 18, whereinthe one or more sacs and the one or more first sensors are configured tomeasure a pressure exerted on the contacting surface by different bodyparts of the user.
 20. The method of claim 19, wherein the device isconfigured to determine a pressure profile based on the pressure exertedon the contacting surface as a function of location and time of contactof the different body parts of the user with respect to the contactingsurface.
 21. The method of claim 20, wherein the pressure profileprovides information on an orientation of the body of the user.
 22. Themethod of claim 21, wherein the information on the orientation of thebody of the user includes data that the user is lying on (a) the leftside of the user, (b) the right side of the user, or (c) the back of theuser.
 23. The method of claim 22, wherein the information on theorientation of the body of the user further includes data on an anatomyof the user.
 24. The method of claim 23, wherein the data on the anatomyof the user include dimensions of the width of the hip of the user. 25.The method of claim 22, wherein device is configured to provide theinformation on the orientation of the body of the user to the userand/or a caregiver.
 26. The method of claim 25, wherein the device isfurther configured to provide recommendations for repositioning the userto avoid pressure ulcers in the user.
 27. The method of claim 26,wherein the one or more first sensors comprise one or more pressuresensors.
 28. The method of claim 27, wherein the one or more pressuresensors record a pressure on the different body parts of the user andprovide one or more pressure sensors data to the caregiver so that thecaregiver may relive an excess pressure from certain body parts of theuser by suitably repositioning the user.